Thoracic Sympathetic Ganglion Block Inadvertent Spread

Thoracic; Sympathetic Ganglion, Injury Clinical Trial

Official title:

Incidence of Inadvertent Intercostal or Epidural Spread During Thoracic Sympathetic Ganglion Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995576
• Other study ID #: 2019-05-028-004
• Status: Completed
• Start date: June 23, 2019
• Est. completion date: August 12, 2019

Study information

• Verified date: September 2019
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study wants to identify the incidence of inadvertend intercostal or epidural spread of thoracic sympathetic block

Description:

Clinically, sympathetic blocks (SB) have been used widely to relieve the symptoms of SMP or to differentiate between SMP and sympathetically independent pain. In order to an SB has a diagnostic value, it requires the successful disturbance of the sympathetic activity for a proper duration of time.

For the diagnosis of SMP using an SB, it is essential achieving complete interruption of the sympathetic activity while preserving the sensory and motor function. The sympathetic trunk at lumbar region runs on the anterolateral surface of the vertebral column from L1 to L4 levels, and deep to the medial aspect of the psoas major muscle. Therefore, the investigators can hardly find epidural contrast spread during lumbar SB due to an anterior location of lumbar sympathetic ganglion to the lateral vertebral body. However, frequent psoas muscle injection can be encountered due to a close proximity of lumbar sympathetic ganglion.

In contrast to lumbar sympathetic ganglion, the thoracic sympathetic ganglion is not separated from somatic nerves by muscles and connective tissue. Moreover, the upper thoracic ganglion runs on the posterior surface of vertebral column with close proximity to adjacent epidural region.

This difference of thoracic sympathetic ganglion leads to a frequent epidural and intercostal spread if the investigators perform thoracic SB. Such spread to epidural and intercostal space lowers the diagnostic value of thoracic SB. In addition, serious adverse outcome can be encountered if neurolytic agent is injected into epidural or intercostal space for the purpose of thoracic sympathectomy. Considering the diagnostic value and safety of thoracic SB, evaluation of actual incidence of occurrence of intercostal and epidural spread is important.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• complex regional pain syndrome

• lymphedema after breast cancer surgery

Exclusion Criteria:

• coagulopathy

• infection

• previous spine fusion at thoracic level

Related Conditions & MeSH terms

• Ganglion Cysts
• Thoracic; Sympathetic Ganglion, Injury

Intervention

Other:
• thoracic sympathetic ganglion block
thoracic sympathetic ganglion block which needle reaches posterolateral vertebral body

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	Daegu
Korea, Republic of	Ji Hee Hong	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of intercostal spread	intercostal spread which appears at fluorosopic view after contrast medium injection	60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block
Primary	incidence of epidural spread	epidural spread which appears at fluorosopic view after contrast medium injection	60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block
Secondary	degree of finger tip skin temperature increase	Skin temperature measurement which is observed after successful sympathetic block	5, 10, 15, 20 minutes after the completion of the intervention 5, 10, 15, 20 minutes mean the time that the outcome was measured after performing the intervention